Two-in-one aortic valve sizing and valvuloplasty conductance balloon catheter.

BACKGROUND: Inaccurate aortic valve sizing and selection is linked to paravalvular leakage in transcatheter aortic valve replacement (TAVR). Here, a novel sizing valvuloplasty conductance balloon (SVCB) catheter is shown to be accurate, reproducible, unbiased, and provides real-time tool for aortic valve sizing that fits within the standard valvuloplasty procedure. METHODS AND RESULTS: The SVCB catheter is a valvuloplasty device that uses real-time electrical conductance measurements based on Ohm's Law to size the balloon opposed against the aortic valve at any given inflation pressure. Accuracy and repeatability of the SVCB catheter was performed on the bench in phantoms of known dimension and ex vivo in three domestic swine aortic annuli with comparison to computed tomography (CT) and dilator measurements. Procedural workflow and safety was demonstrated in vivo in three additional domestic swine. SVCB catheter measurements had negligible bias or error for bench accuracy considered as the gold standard (Bias: -0.11 ± 0.26 mm; Error: 1.2%), but greater disagreement in ex vivo versus dilators (Bias: -0.3 ± 1.1 mm; Error: 4.5%), and ex vivo versus CT (Bias: -1.0 ± 1.6 mm; Error: 8.7%). The dilator versus CT accuracy showed similar agreement (Bias: -0.9 ± 1.5 mm; Error: 7.3%). Repeatability was excellent on the bench (Bias: 0.02 ± 0.12 mm; Error: 0.5%) and ex vivo (Bias: -0.4 ± 0.9 mm; Error: 4.6%). In animal studies, the device fit well within the procedural workflow with no adverse events or complications. CONCLUSIONS: Due to the clinical relevance of this accurate, repeatable, unbiased, and real-time sizing measurement, the SVCB catheter may provide a useful tool prior to TAVR. These findings merit a future human study.

A lumen sizing workhorse guidewire for peripheral vasculature: two functions in one device.

OBJECTIVES: Ideally, guidewires used during peripheral vasculature (PV) interventions could serve both as a therapy delivery platform and a diagnostic tool for real-time vessel sizing (2-in-1 function). BACKGROUND: Vascular imaging modalities, like intravascular ultrasound (IVUS), used during lower PV interventions, can improve outcomes versus angiographic assessment alone, but are rarely used due to added time, cost, and required clinical training/interpretation. METHODS: A 0.035″ bodied 0.035″ conductance guidewire (CGW) is described here as a vascular navigation and diagnostic real-time PV sizing tool. When attached to a console, the CGW creates a safe, electric field to determine vascular size through simultaneous voltage measurements. RESULTS: The CGW showed functionality as a workhorse guidewire on the bench (torqueability and trackability equivalent to a Wholey guidewire) and in vivo (over-the-wire stent deployment in domestic swine and first-in-man study with no major adverse events). Validation of CGW sizing versus the true diameter and IVUS was completed in 4-10 mm diameter phantoms on the bench and in swine and showed virtually no bias with excellent repeatability and accuracy (i.e., CGW repeatability: swine phantom bias = 0.03 ± 0.09 mm (1.3% error). CGW vs. true diameter: in vivo bias = 0.14 ± 0.15 mm (2.7% error). IVUS vs. true diameter: swine phantom bias = 0.01 ± 0.36 mm (4.7% error). CCW vs. IVUS: swine phantom bias = 0.13 ± 0.26 mm (3.8% error)). CONCLUSIONS: Real-time, accurate, and safe PV dimension assessment and therapy-delivery (2-in-1 function) is possible using a novel workhorse 0.035″ bodied CGW.

Conductance sizing balloon for measurement of peripheral artery minimal stent area.

BACKGROUND: Because stent underdeployment occurs frequently, accurate minimal stent area (MSA) measurement during postdilatation is necessary. This study investigated the accuracy and repeatability for MSA determination using a novel conductance balloon (CB) catheter for peripheral vessels. METHODS: The CB catheter is a standard balloon catheter that measures electrical conductance (ratio of current/voltage drop) in real-time during inflation, which directly relates to the balloon cross-sectional area through Ohm's law. CB measurements were made in 4- to 10-mm phantoms on the bench, ex vivo in stents fully deployed in diseased human peripheral arteries, and in vivo in stents fully deployed in peripheral vessels in six swine. CB measurement accuracy and repeatability were calculated and compared with the known dimension (bench phantoms) or with intravascular ultrasound (IVUS) measurement after stent deployment (ex vivo and in vivo). RESULTS: CB measurements were highly accurate (error: 1.8% bench, 5% ex vivo, and 5% in vivo) and repeatable (error: 0.9% bench, 1.8% ex vivo, and 1.3% in vivo), with virtually no bias (average difference in measurements: -0.05 mm bench CB vs known phantom diameters, -0.06 mm ex vivo CB vs IVUS, and -0.11 mm in vivo CB vs IVUS). CONCLUSIONS: The CB sizing capability can be integrated within a standard balloon catheter (two-in-one function) to provide accurate, real-time assessment of MSA to ensure full stent apposition rather than the use of pressure as a surrogate for size.

Accurate nonfluoroscopic guidance and tip location of peripherally inserted central catheters using a conductance guidewire system.

BACKGROUND: Bedside placement of peripherally inserted central catheters (PICCs) may result in navigation to undesirable locations, such as the contralateral innominate or jugular vein, instead of the superior vena cava or right atrium. Although some guidance and tip location tools exist, they have inherent limitations because of reliance on physiological measures (eg, chest landmarks, electrocardiogram, etc), instead of anatomical assessment (ie, geometric changes in the vasculature). In this study, an accurate, anatomically based, non-X-ray guidance tool placed on a novel 0.035" conductance guidewire (CGW) is validated for PICC navigation and tip location. METHODS: The CGW system uses electrical conductance recordings to assess changes in vessel cross-sectional area to guide navigation of the PICC tip. Conductance rises and oscillates when going in the correct direction to the superior vena cava/right atrium, but drops when going in the incorrect direction away from the heart. Bench and in vivo studies in six swine were used to confirm the accuracy and repeatability of the PICC placement at various anatomical locations. The PICC tip location was confirmed by direct visualization vs the desired location. RESULTS: CGW PICC guidance was highly accurate and repeatable with virtually no difference between actual and desired catheter tip location. The difference between the CGW PICC location vs the desired target was -0.07 ± 0.07 cm (6.6% error) on the bench and 0.04 ± 0.10 cm (5% error) in vivo. No complications or adverse events occurred during CGW usage. CONCLUSIONS: The CGW provides an anatomically based, reproducible, and clinically significant method for PICC navigation and tip location that can improve accuracy, decrease the wait time prior to therapy delivery, decrease cost, and minimize the need for X-ray. These findings warrant clinical evaluation of this navigation tool for PICC line placement.

Contribution of BK(Ca) channels to local metabolic coronary vasodilation: Effects of metabolic syndrome.

This investigation was designed to examine the hypothesis that impaired function of coronary microvascular large-conductance Ca(2+)-activated K(+) (BK(Ca)) channels in metabolic syndrome (MetS) significantly attenuates the balance between myocardial oxygen delivery and metabolism at rest and during exercise-induced increases in myocardial oxygen consumption (MVo(2)). Studies were conducted in conscious, chronically instrumented Ossabaw swine fed a normal maintenance diet (11% kcal from fat) or an excess calorie atherogenic diet (43% kcal from fat, 2% cholesterol, 20% kcal from fructose) that induces many common features of MetS. Data were collected under baseline/resting conditions and during graded treadmill exercise before and after selective blockade of BK(Ca) channels with penitrem A (10 microg/kg iv). We found that the exercise-induced increases in blood pressure were significantly elevated in MetS swine. No differences in baseline cardiac function or heart rate were noted. Induction of MetS produced a parallel downward shift in the relationship between coronary venous Po(2) and MVo(2) (P < 0.001) that was accompanied by a marked release of lactate (negative lactate uptake) as MVo(2) was increased with exercise (P < 0.005). Inhibition of BK(Ca) channels with penitrem A did not significantly affect blood pressure, heart rate, or the relationship between coronary venous Po(2) and MVo(2) in lean or MetS swine. These data indicate that BK(Ca) channels are not required for local metabolic control of coronary blood flow under physiological (lean) or pathophysiological (MetS) conditions. Therefore, diminished function of BK(Ca) channels does not contribute to the impairment of myocardial oxygen-supply demand balance in MetS.